A Randomized, Double-Masked, Parallel-Group, Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension SPECTRUM 6 Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Santen Inc.
- 入组人数
- 98
- 试验地点
- 13
- 主要终点
- Intraocular Pressure (IOP) at Week 2
研究概览
简要总结
This is a randomized, double-masked, parallel-group, multi-center study. Subjects diagnosed with POAG or OHT who meet eligibility criteria at Visit 1 (Screening) will wash out their current topical IOP lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at Visit 2 (Baseline, Day 1) will be randomized to receive study medication for up to 6 weeks.
Approximately 100 subjects with POAG or OHT will be randomized in a 1:1 ratio to either:
- DE-117 ophthalmic solution 0.002% QD (Once Daily)
- DE-117 ophthalmic solution 0.002% BID (Twice Daily)
This study will consist of a screening period of up to 35 days including a washout period of up to 28 days (+ 7 days window), and a 6-week double-masked treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide signed written informed consent
- •Have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT.
- •Qualifying corrected visual acuity in each eye
- •Qualifying central corneal thickness in each eye
- •Qualifying Day 1 IOP measurement at 3 time-points in both eyes
- •Qualifying Anterior chamber angle
排除标准
- •History of ocular surgery specifically intended to lower IOP
- •Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period
- •Advanced glaucoma in either eye
- •Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry
- •Any ocular surgery or ocular laser treatment within 180 days prior to Screening and throughout the study in either eye
- •Females who are pregnant, nursing, or planning a pregnancy
研究组 & 干预措施
Drug Arm: DE-117 QD
DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD
干预措施: DE-117 Ophthalmic Solution QD (Drug)
Test Arm: DE-117 BID
DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)
干预措施: DE-117 Ophthalmic Solution BID (Drug)
结局指标
主要结局
Intraocular Pressure (IOP) at Week 2
时间窗: 16:00 at week 2
Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...
Intraocular Pressure (IOP) at Week 6
时间窗: 16:00 at week 6
Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...
次要结局
- Mean Diurnal Intraocular Pressure (IOP)(6 weeks)